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Head of PV Excellence

Location: Tokyo, Tokyo JP

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Job Number: 1364

External Description:

  • Manage all aspects of PV Excellence Team to meet required GXP compliance as well as to contribute optimization of company's business. Specifically:
    • Prepare, track and ensure timely submission of local periodic reports (J-PSR, ReSD, Non-serious unlisted ADR periodic report, non-serious unlisted PTC periodic report, J-DSUR, Infection periodic report).
    • Prepare, track, and timely submission of GXP reports (Research report/Safety Measure Report).
    • Collaborate with CSU and RA departments to plan for PSRs
    • Coordination of local divestment projects and partnership
    • People management
    • Vendor management (multiple vendors)
  • REQUIREMENTS
    • Advanced knowledge of local pharmacovigilance legislation
    • Understanding of global requirements for pharmacovigilance by major health authorities.
    • Ability to analyze, connect and interpret complex information from multiple sources and drive thoughtful risk-taking and decision-making
    • Problem solving skills, excellent communication to a diverse audience
    • Excellent project management skills
    • Knowledge of Aggregate report tool with understanding of both business and technical requirements
    • Inclusive leader with soft skills
    • Knowledge of budget forecasting and management
    • Native level oral and written Japanese. Advanced fluency in English

Job Number: 1364

Community / Marketing Title: Head of PV Excellence

Location_formattedLocationLong: Tokyo, Tokyo JP